RYANODEX® is supplied as 250 mg vials of dantrolene sodium in lyophilized powder form. It is reconstituted with 5 mL of sterile water for injection (non-bacteriostatic). Its formulation allows for reconstitution and administration in less than 1 minute to patients experiencing MH1,7

Upon reconstitution, RYANODEX® is a suspension of dantrolene sodium which should be administered by intravenous push7

Dantrolene sodium is the standard of care for malignant hyperthermia (MH) treatment, and since 1979, has been one of the only pharmacotherapies available to reverse an MH episode.17 The following chart provides an overview of the primary differences between RYANODEX® (dantrolene sodium) for injectable suspension and other dantrolene sodium IV products:

Each vial of RYANODEX® (dantrolene sodium) for injectable suspension contains only 125 mg of mannitol (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis) compared with 3000 mg of mannitol in each vial of other dantrolene sodium for injection products.5-7

Other formulations of dantrolene sodium for injection are a lyophilized (dry), fluffy, light orange powder. RYANODEX® (dantrolene sodium) for injectable suspension differs from this in that it is a deep orange lyophilized (dry) cake with a lightened meniscus edge.1

MHAUS recommends stocking a minimum of 700 mg dantrolene sodium, which is supplied in only 3 vials of RYANODEX® (dantrolene sodium) for injectable suspension (in contrast to the 36 vials required to obtain 700 mg with other dantrolene sodium IV products).18

Data suggest that the average patient uses a median dose of 5.9 mg/kg of dantrolene sodium in a crisis. For many patients, this is less than the recommended 700 mg. Check with your accrediting body and MHAUS.org for additional information.14

RYANODEX® (dantrolene sodium) for injectable suspension should be reconstituted with 5 mL sterile water for injection (without a bacteriostatic agent). Shake the vial until RYANODEX® is mixed thoroughly (should take less than 10 seconds). Suspension should be a uniform orange suspension. Please refer to the Reconstitution and Administration Instructions section (2.4) of the Prescribing Information.1,7

Reconstituted RYANODEX® (dantrolene sodium) for injectable suspension should be used within 6 hours after reconstitution. Store reconstituted suspension at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light.7

RYANODEX® (dantrolene sodium) for injectable suspension should be reordered as soon as possible after use or about 1 to 2 months before expiration. Similar to other dantrolene sodium IV products, RYANODEX® cannot be returned for credit. Expired product should be discarded.

Eagle has developed a reconstitution and administration video, a reconstitution and administration dosing card, and other informational tools to educate medical practitioners on how to use RYANODEX® (dantrolene sodium) for injectable suspension. Go to RYANODEX.com/educational-tools-and-support for more information.

Malignant hyperthermia (MH) is a hypermetabolic condition that can be triggered when genetically susceptible individuals come in contact with certain inhaled (volatile) anesthetics or the muscle relaxant succinylcholine.10

Dantrolene sodium is the only known antidote for malignant hyperthermia (MH) induced by inhalational anesthetics in humans and is recognized as the only standard treatment for MH. The use of RYANODEX® (dantrolene sodium) for injectable suspension in the management of MH crises is not a substitute for previously known supportive measures. These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. Patients who receive IV dantrolene sodium preoperatively should have vital signs monitored.7,8

During an MH crisis, additional advice can be obtained by calling 800.MH.HYPER (800.644.9737)

To report a RYANODEX® related adverse event, or for other information on RYANODEX®, please contact Eagle Customer Service Team: 855.318.2170

Important Safety Information

RYANODEX® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia (MH), including discontinuing use of MH-triggering anesthetic agents, managing the metabolic acidosis, instituting cooling when necessary, and administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis).

RYANODEX® is associated with skeletal muscle weakness such as loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea, and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to prevent extravasation of RYANODEX® into the surrounding tissue due to the high pH of the reconstituted RYANODEX® suspension and potential for tissue necrosis.

Indication

RYANODEX® (dantrolene sodium) for injectable suspension is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.